Basilea has been hurt after regulators in the USA told the Swiss firm’s partner Johnson & Johnson that it cannot approve a New Drug Application for the antibiotic ceftobiprole in its present form.

The US Food and Drug Administration has issued a complete response letter concerning ceftobiprole which has been filed for the treatment of complicated skin and skin structure infections. J&J says that the agency has requested additional information and recommended additional clinical studies be conducted, but Basilea has provided far more detail which does not reflect well on its US partner.

The FDA says that data from studies BAP00154 and BAP00414 “cannot be relied upon” because inspections and audits of one-third of the clinical trial sites for these studies “found the data from a large proportion of these sites to be unreliable or unverifiable”. This raised concerns regarding the overall data integrity for both studies, the Swiss firm notes.

The agency also claimed that J&J “failed to adequately monitor the clinical investigators’ conduct of these studies”, as outlined in its warning letter issued in August to the US healthcare giant. The FDA now recommends that “in order to address the deficiencies”, two new “adequate, and well-controlled studies to evaluate the safety and efficacy of ceftobiprole for the treatment of cSSSI should be conducted”.

This is not the first time the FDA has delayed approval of the drug and regulators in Europe have also demanded audits of clinical sites. The European Medicines Agency’s Committee for Medicinal Products for Human Use is expected to give an opinion on ceftobiprole in the first quarter of 2010.

Damages claim
The FDA’s misgivings has led to Basilea increasing a damages claim against J&J submitted in February as part of a request for arbitration under the companies' licence agreement for ceftobiprole. A resolution to the arbitration is expected before the end of 2010 and Basilea added that it is “reviewing all strategic options to protect the interests of the company and its shareholders”.